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Actively Recruiting
Researchers are evaluating the safety and effectiveness of IMVT-1402 in adults with moderate to severe primary Sjogrens disease, a condition characterized by systemic symptoms. This Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study aims to compare IMVT-1402 to a placebo by measuring changes in disease activity at 24 weeks. Participants will receive weekly subcutaneous injections of either IMVT-1402 at one of two doses or a placebo. The study includes a treatment phase with dosing and monitoring, followed by ongoing participation lasting up to 105 weeks total for each individual. Throughout the study, participants will undergo regular assessments including clinical disease activity scoring using the Clinical European League Against Rheumatism Sjogrens Syndrome Disease Activity Index clinESSDAI. Additional evaluations include physician assessments of disease activity and antibody testing. Safety and tolerability will be closely monitored during the entire study duration.